Drug recall
Excelsior Disposable Syringe Heparin Lock Flush, USP syringe (5 mL Fill in 10 mL syringe). For flushing of IV…
FDA recall event 74045 · Class II · Excelsior Medical Corp
Key facts
| Event ID | 74045 |
|---|---|
| Recall numbers | Z-1989-2016 |
| Recalling firm | Excelsior Medical Corp |
| Product type | Devices |
| Products | Excelsior Disposable Syringe Heparin Lock Flush, USP syringe (5 mL Fill in 10 mL syringe). For flushing of IV catheters and IV tubing only. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Certain lots of Heparin Lock Flush, USP Syringes (5 ml Fill in 10 ml Syringe) failed Anti-Factor IIa assay for potency during testing of retention samples for heparin potency. |
| Initiation date | Apr 28, 2016 |
| Report date | Jun 22, 2016 |
| Termination date | Aug 8, 2017 |
| City | Neptune |
| State | NJ |
| Country | United States |
| FEI number | 1000122362 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: